In Memoriam

We are deeply saddened by the passing of one of PRIM&R's founders and longtime board presidents (1979-2001) Sanford Chodosh, MD, who died peacefully, surrounded by his large and loving family, on August 30, 2010.

Sanford Chodosh, a clinical investigator for more than 40 years, retired from the Boston University School of Medicine where he was an Associate Professor and from the VA Outpatient Clinic in Boston, Massachusetts, where he was Chief of Staff for 14 years and Chief of Pulmonary. Dr. Chodosh authored or coauthored more than 73 articles, 38 abstracts, and 40 chapters in books and monographs. He was involved in a number of hospital and organization activities and received numerous awards and honors. Dr. Chodosh served as the IRB chair at the Boston City Hospital from 1971-1984. Through the time of his passing, he continued to be deeply involved with the protection of human and animal subjects in research as a founder of PRIM&R. In 2005, he received PRIM&R’s Founders’ Award in recognition of his long service to the organization.

Dr. Chodosh looked to PRIM&R as his “second family” and provided the organization with vital leadership from its earliest beginnings. He was a positive example to all of PRIM&R, having lived each day with courage, strength, wisdom and dignity.

Joan Rachlin, PRIM&R’s executive director, knew Dr. Chodosh for more than 35 years, and extended her sympathy to his wife, Harriet, and his children and grandchildren. She noted that Dr. Chodosh will be sorely missed by his many friends, colleagues, and loved ones in his PRIM&R family, in the community of pulmonologists of which he was a respected researcher/clinician, and among the many devoted stamp collectors who shared another of his passions. Ms. Rachlin noted that “Sandy was PRIM&R's most visible and venerable leader for over two decades, and that leadership is part of his lasting legacy. His memory will always be a blessing.”

Read more about Dr. Chodosh’s reflections of 25 years with PRIM&R, which was written in 1999. Please add your reminiscences and/or condolences the comments section below. PRIM&R will make sure to share them with Dr. Chodosh’s family.

Judge halts federal stem cell aid

Yesterday, a federal district judge temporarily blocked the Obama administration’s 2009 executive order that created an opportunity for expanded embryonic stem cell research. According to an article in today's Boston Globe, the judge made his decision because “regulations designed to expand federal funding for embryonic stem cell research violated a law prohibiting destruction of embryos for research purposes.”

Beginning in March 2009, the Obama administration’s order allowed researchers to work with embryonic stem cells from donated embryos, with donor consent. Now, stem cell researchers that began work after the 2009 order must decide whether to abandon the new projects or find funding that does not involve federal dollars.

How do you think this ruling will affect stem cell research, and biomedical research as a whole? And, how can researchers and IRBs comply with this ruling without abandoning valuable progress in these studies?

Planning Committee Profile: Ivor Pritchard

Planning Committee (PC) Profile: Ivor Pritchard, 2010 Advancing Ethical Research Conference PC Co-Chair

How might you explain your work to someone who is new to the field of research ethics?
I work for the U.S. Department of Health and Human Services. Our office—the Office for Human Research Protections—has regulatory authority over how people are protected when they volunteer to participate in research studies of various kinds, including clinical trials.

The regulations require independent committee approval of research studies and ordinarily require consent from the people involved before they start participating in research. Our office coordinates education events, develops policy, and carries out enforcement activities related to the regulations.

What motivated you to choose a career in research ethics?
I got into a career in research ethics largely by accident. As a graduate student in philosophy, I was assigned to be a teaching assistant in a medical ethics course, and the course included the ethics of experimentation. I later included medical ethics among the courses I taught as a college professor. Later on, after I moved to a position in the research program office of the U.S. Department of Education, I was asked to attend a meeting in 1990 about whether the department should join with other agencies in adopting regulations about the protection of human subjects in research. This, of course, turned out to be the process leading up to the adoption of the Common Rule in 1991. The rest is history.

What’s the most rewarding part of your job?
What’s most personally rewarding is when people learn something valuable from an educational presentation. What’s most intellectually rewarding is figuring out better ways to shape policy regarding regulatory provisions and the practice of ethical research.

How did you become involved with PRIM&R?
When I was at the U.S. Department of Education in the early 1990s, Congress was debating various legislative proposals related to surveys asking students for sensitive personal information about themselves. PRIM&R asked me to come and talk about those proposals at some of their meetings. (Eventually, the legislation was passed as the Protection of Pupil Rights Amendment.)

What are your goals for the 2010 Advancing Ethical Research Conference?
To be all things to all people: I want beginners, old hands, IRB members, IRB administrators, human subjects, oncologists, ethnographers, philosophers, and even Yankee fans to be able to find good learning experiences somewhere during the conference.

Which topics will the conference program address that you find most intriguing, or in need of attention, especially given today’s ever-changing regulatory environment?
The topics I find most intriguing are the ones where the ethical principles collide, such as when the principles of respect for persons and beneficence point in contrary directions. What needs the most attention is how well—or how poorly—the ordinary routine practices of human research protection programs serve to advance the goods that we’re trying to achieve related to protecting the rights and welfare of research subjects.

In addition to the keynotes, panels, and sessions, our conference has so many other highlights (i.e., networking sessions, book group, and more). What are you most looking forward to?
Meeting people who don’t live near Washington, DC, both people I know and people I’ve never met before.

Where is your hometown?

For most of my childhood I lived in Waccabuc, NY, which at that time wasn’t even a town.

What’s playing on your iPod? (What music do you listen to?)
Sarah McLachlin, Randy Travis, Eric Clapton, Sade, Matchbox 20, Cheryl Wheeler, Ray Charles, Alison Krauss, Fayrouziat Fadi, among others.

What are you reading?
Commuting on the Metro, I read The New Yorker magazine religiously. The last book I read was Neil Gaiman’s The Graveyard Book.

What is your favorite type of food?
Italian and Lebanese. (My wife is half Italian and half Lebanese, not coincidentally.)

If you had to choose one…

Sweet or salty? Salty

Classical music or rock? Rock

Circle or square? Circle

Dogs or cats? Dogs

City or country? Country

Silver or gold? Gold

Swimming or hiking? Hiking

Featured Member Interview: Christian LaMantia

As an extension of our Member Appreciation Month series of member interviews, we will continue to introduce you to more of our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Christian LaMantia, President of Research Compliance Counselor, LLC.

When and why did you join the field?

In 1997, after working in a research lab by day and completing my MBA in marketing and technology management at night, I decided to pursue my dream of commercializing new technologies at the university I was working for at the time.

The VP for research who interviewed me stated that she didn’t have any openings, but if I would take a job in research administration that included some “compliance” responsibilities, she could get me into the new tech transfer position she was creating in a “couple of months.”
After the interview, I went in search of information about the federal regulations on human subject research, as I had no idea what she was talking about. This was the first of many nights over the next decade that I would find myself in bed with 45 CFR 46.

I never did get the position in tech transfer. Actually, the VP who hired me resigned my first day on the job. But after 13 years of painstaking (and sometimes heartbreaking) work in this field, I have to say I have no regrets. We get to work with amazing, brilliant people and we have a chance to make a difference in the lives of both the subjects and the physicians/scientists. I am definitely ready for the next 13 years!

What is your favorite part of your job?

As a regulatory consultant, I get the opportunity to talk about research compliance at every level of an organization, from presidents and IRB directors, to investigators and trainees. I am always gratified to share with them that they are not alone in their challenges and that there are reasonable solutions.

At conferences, I think we tend to discuss the very best and very worst case scenarios in our field, and are hesitant to address the sometimes ugly but benign details (85 percent of the workload) that fall in the middle. When I share my personal stories, clients often say, “I thought this kind of stuff only happened at our institution.” Relief washes over their face, the light bulb goes on, and then they are ready to tackle whatever challenge they have hired me to help them with. This is my favorite part of the job.

What are three websites you visit on a daily basis?

Napoleon Hill and Ted.com (both for inspiration), and weather.com (I do live in the Snow Belt!)

What was the last book you read?

I just finished reading The Immortal Life of Henrietta Lacks. Great book!

Why did you join PRIM&R?

Initially I joined to learn more about the field. Over the years I’ve stayed because of the great membership [benefits].

What is your favorite member benefit?

I like the Newsletter as it saves me time and effort by linking me to articles and updates.

With whom have you made a lasting professional connection through your membership?

Ada Sue Selwitz’s humor always reminds me how important it is to be true to yourself in this job.

What do you believe is a key challenge facing the field of research ethics?

I think our field is facing another period of dramatic change. It is no longer “good enough” to have a well-run IRB, IACUC, or conflict of interest committee. All elements of a research compliance program must be coordinated and transparent as research becomes less discipline-specific. Professionals in our field not only need research ethics training to succeed, but also business management, interpersonal skills, and technology training. Working for researchers in the field has taught me that efficiency and good customer service not only help to promote research, but actually improve human subject protections.

Thank you for being part of the membership community and sharing your story, Christian. We hope you can join us in San Diego for Rebecca Skloot’s keynote address and our Research Ethics Book Group lunch!

If you’d like to learn more about becoming a member, please visit our website today.

Back to basics: A quick reminder on facing ethical dilemmas

By: Vinita J. Witanachchi, JD

An ethical dilemma is defined as “a situation that will often involve an apparent conflict between moral imperatives, in which to obey one would result in transgressing another.” As researchers, we face ethical dilemmas in our everyday professional lives.

When you are faced with an ethical dilemma as a researcher, how do you handle it? Though you may have your own methods, I believe that sometimes it helps to take a step back and try some new approaches. No matter where you are in your career, it might be helpful to:

• Discuss the situation with a senior researcher, or another co-worker, who may have already encountered a similar situation. You never know what their perspective will bring.


• Familiarize yourself with the accepted ethical standards and, if you need to, consult with a subject matter expert.


• Ask more questions! Gather as much information as possible by talking to colleagues from other institutions and exploring different options. No matter what you find, as a researcher, you need to make choices.

Additionally, you will have to justify your decisions, and articulate your thought process in arriving there. It can never hurt to ask yourself personal questions such as:

• Which of the options is the most just, respectful, and beneficent?


• What does my instinct say?


• How would the wisest person you know in your professional life react to a similar situation?


• Which of the options will have the best overall result?


• Which option may bring on publicity and/or scrutiny?

While there is no guarantee that one’s subjective reasoning will align with accepted ethical standards, if you take a moment and go back to basics, you’re more likely to be comfortable enough to defend your position and the reasoning behind it.

Are you a PRIM&R member who’s interested in contributing to Ampersand? Contact us at 617.423.4112 ext. 14 or by e-mail, and learn more about being a PRIM&R guest blogger.

An inside look at SACHRP

By David Borasky, PRIM&R board member

Recently, the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) met for the twenty-third time in seven years to, in the words of its charter, “provide expert advice and recommendations to the Secretary and the Assistant Secretary for Health (ASH) on issues and topics pertaining to or associated with the protection of human research subjects.” The committee is comprised of 11 experts in ethics, biomedical research, social/behavioral research, institutional review board (IRB) professionals, and subject advocates. In addition, representatives of the FDA and numerous Common Rule agencies participate in the discussions as ex officio members.

Since its first meeting, the SACHRP has conducted in-depth examinations on a wide variety of topics related to human subject protections. To that end, SACHRP has convened various subcommittees to discuss topics such as accreditation, harmonization, and individuals with impaired decision-making abilities.

In consultation with the numerous expert panels that have presented at their meetings, SACHRP continues to gather information and craft recommendations, many of which have successfully informed new and draft guidance documents issued by the Office for Human Research Protections (OHRP).

At its most recent meeting, the SACHRP treated observers to several impressive presentations, including:

• A presentation on internet research and the ethical issues it poses. The presenters debated questions such as, “How will reviewing studies in the virtual world be challenging for institutional review boards (IRBs)?”


• A panel describing how various institutions have developed ethics consultation services for their research communities. This panel also considered the role of the IRB with respect to these consultations.


• One subcommittee worked with SACHRP to finalize a set of more than 20 frequently asked questions on IRB requirements for research involving biospecimens. Audience members listened in as the SACHRP worked to craft language on specimens that would meet OHRP, the Office for Civil Rights, and the HIPAA Privacy Rule’s standards.
  
• Finally, PRIM&R board members Pearl O’Rourke and Bill Freeman joined members of the Havasupai Tribe in making emotional presentations on the Havasupai DNA rights case.

Every presentation panel featured experts who can be found on past and present PRIM&R faculty lists, and all of these presentation topics will be covered at the 2010 Advancing Ethical Research Conference.

What you may not know about SACHRP, though, is that the meetings are held three times per year in the Washington, DC, area, and are free and open to the public. Individuals who attend SACHRP meetings are fortunate to witness robust discussions between the committee, presenters, invited guests, OHRP staff, and the ex officio members. If being a fly on the wall isn’t exciting enough, there are opportunities for networking with SACHRP members, presenters, and observers, as well as time reserved for public comment at the end of each day.

The SACHRP website, which is maintained by OHRP, contains minutes of past meetings as well as presentation materials, copies of correspondence with the Secretary for Health and Human Services, and the schedule of upcoming meetings. I know that I will be attending the SACHRP meetings in the future, and hope to see my colleagues from the HRPP field there, too.

Featured Member Interview: Lauren Perez

As an extension of our Member Appreciation Month series of member interviews, we will continue to introduce you to more of our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Lauren Perez, IRB manager at New York University Langone Medical Center.

When and why did you join the field?
I joined the field close to four years ago, starting as a research coordinator; I now work for the institutional review board (IRB).

Anyone who knows me will readily affirm that my favorite question is “why?” My mother always tells the story of the first time I watched a scary movie when I was a little girl. It happened to be Nightmare on Elm Street. She was waiting for me to say I was too scared to go to sleep after watching Freddy Krueger, but instead I was quiet for a few minutes before turning to her and saying, “I wonder why people hurt other people.”

Research is the work that aims to answer “why,” a question with an endless scope of focus. Working both on a research team and as a member of IRB staff allows me to play a role in helping to answer those questions, while ensuring human subject protections.

What is your favorite part of your job?
My favorite part is working through the ethical considerations that arise in human subject protections. There is no black-letter law on how to manage each situation, and scientific and technological advancement occurs significantly faster than our regulations can catch up.

Creating a balance between advancing research and protecting subjects in studies that test regulatory principles is the best way that we can handle this, as approval requirements are so unique that we often confront the fact that we need to make the best decision for both sides. Needless to say, there are rarely dull moments. Considerations for minorities in research and non-English speaking subjects are of specific interest to me.

What is the last movie you saw?
American Gangster. I did not get to see it while it was in the theater!

What's your after-hours guilty pleasure?
At the risk of sounding rather boring, my guilty pleasures are crossword puzzles and reading books unrelated to schoolwork. I will be graduating with a masters of social work from New York University in May 2011, so my reading is usurped by school assignments. Every time I pick up the newspaper for the puzzle, my conscience nags me about an assignment that I should be doing for school!

Why did you join PRIM&R?
I joined as part of the “Registration plus membership” option for the 2009 Advancing Ethical Research Conference.

What is your favorite member benefit?
My favorite benefit is the Newsletter. It always keeps me updated on the latest hot-button topics in research, and informs me of all the upcoming webinars PRIM&R will hold to discuss them.

If you were planning our next conference, who would you select as a keynote speaker?
While I do not have a specific person in mind, I think that I would select a research participant. We make decisions based on what we think is ethical and practical, but I believe that hearing directly from the people who we work to protect is fundamental in helping us to make the best determinations.

What do you believe is a key challenge facing the field of research ethics?
Informed consent, informed consent, informed consent!

This issue is not as clear-cut as it sounds. There is a stark difference between “consent” and “informed consent.” Simple consent is giving someone permission for something. Informed consent involves two necessary components: that the person has all of the information necessary to make their decision, and that the person is competent enough to make said decision.

There are obvious situations when competence comes into play, such as research involving subjects who might be cognitively impaired. However, there are other issues that are just as important in making this determination. Are the subjects being enrolled fluent in the language of the research team? Were the subjects “tested” or asked to explain what they understood from the consent process? Is the research explained in an age-appropriate way to children when they are involved?

A signed informed consent document does nothing to show that the subject understood what they were getting involved in, just that they gave permission. We also see this issue of informed consent arising in this age of genetic research, especially in samples collected with consent to be stored for future research. What is the balance? How can we meet the criteria of “informed consent” for situations in which testing is done that we could have never predicted years ago when consent was originally obtained? This issue of informed consent is really at the forefront of the field, and one that we struggle to navigate in our mission to advance science through ethical research.

Thank you for being part of the membership community and sharing your story, Lauren. Good luck on all those crosswords!

If you’d like to learn more about becoming a member, please visit our website today.

FDA approves first human test of embryonic stem cell treatment

Federal regulators have cleared Geron, a California biotechnology company, to proceed with the world’s first test of embryonic stem cell treatment on patients with spinal cord injuries.

The Food and Drug Administration (FDA) revoked a clinical hold on the study that was put in place last summer when Geron revealed that mice had developed cysts during the experiment. FDA officials declined to comment on why they decided to lift their hold on the study.

With patient recruitment could begin as early as next month, many of the ethical questions—that initially delayed Geron’s study—remain unanswered.

If part of the study’s intention is to test the safety of stem cell treatment, how would the informed consent be structured? How can Geron address ethical issues raised by the use of embryonic stem cells? How might this research affect peer organizations that are also working toward similar goals? How might the roles and responsibilities of institutional review boards (IRBs) and embryonic stem cell research oversight (ESCRO) committees change if this type of research becomes more mainstream?